Abstract: Five Eleven Pharma is developing a simple, low-cost device for automating the preparation of Ga-68 labeled drugs at any site that is performing PET imaging. The device is being developed to support the broader creation, distribution, research and use of Ga-68 compounds in diagnostic PET imaging. There has been a surge in the use of Ga-68-based radiopharmaceuticals throughout the world in the past several years, particularly in Europe where about 100 centers provide various Ga-68 investigational agents. The success of these drugs, first of 68Ga-DOTATOC and related somatostatin receptor binding peptides, and more recently agents targeting prostate cancer such as PSMA-11, is fueling much of this expansion in Europe, and similar growth is expected in the United States, where DOTATOC received orphan drug status by the US FDA in 2013. Today, however, only a few academic sites in the US provide all the Ga-68-based drugs needed to meet patient demand, often through expanded access Investigational New Drug (IND) clinical trial protocols. In many cases PET imaging with Ga-68 labeled drugs are the best available diagnostic procedure available to patients for the detection of disease, yet access to these new drugs is limited. Because of the short half-life (68 min) of Ga-68, it will be difficult for existing radiopharmacy networks (that were designed for distribution of radiopharmaceuticals with longer half-lives (>= 110 minutes)) to deliver Ga-68 drugs efficiently. On-site preparation of Ga-68 drugs is expected to grow in response to this distribution problem. Five Eleven will meet this growing demand through a device that will require little expertise to operate and maintain, and fully automates the process for producing a sterile, injectable Ga-68 radio-labeled drug. The device will be based on industry-standard, single-use disposable components and will use no externally connected computer or other device to operate since it will have no changeable operating parameters. Our aims for the project are to 1) optimize the operating parameters of the device to effectively reduce the control system and hardware to bare minimums reducing cost significantly (by 10 X) compared to existing systems. Aim 1 will evaluate fluid drive pressure/vacuum, flow rate and temperature to establish the sensitivity of the yield and purity of the final product to each of these parameters. 2) Develop a fully automated device based upon a minimum hardware configuration and fixed control system; and 3) Demonstrate an automated system by producing 3 Ga-68 compounds P15-041, PSMA-11 and DOTATOC that meet all the quality criteria required by the FDA for injectable Ga-68 labeled drugs (pH, tonicity, radiochemical purity >90%, radiochemical identity, Ge-68 content < 0.001%, radionuclidic purity, radionuclidic identity and sterility). Successful completion of this phase I will lead to full commercial development of a device in phase II with testing in a clinical study using either proprietary or generic new Ga-68 drugs produced at the clinical PET imaging site. Page 1 of 1